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Saxenda – Incretin mimetic (GLP-1 receptor agonist) given by subcutaneous injection once daily
Victoza is used to improve glycemic control in adults with type 2 diabetes mellitus (DM) and to reduce the risk of non-fatal cardiovascular events (e.g., myocardial infarction or stroke), including reduction of cardiovascular mortality, if patients also have cardiovascular disease
Separate product (Saxenda) used for reduction of obesity as an adjunct to diet and exercise in adults
Liraglutide products are not recommended as a first-line therapy due to the boxed warning regarding rodent C-cell tumor findings and the uncertain relevance to humans
·INDICATIONS AND USAGE
Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated
as an adjunct to a reduced-calorie diet and increased physical activity for
chronic weight management in adult patients with an initial body mass
index (BMI) of
or greater (obese) (1) or
or greater (overweight) in the presence of at least
one weight-related comorbid condition (e.g. hypertension,
type 2 diabetes mellitus, or dyslipidemia) (1).
Limitations of Use:
Saxenda is not indicated for the treatment of type 2 diabetes (1).
Saxenda should not be used in combination with any other GLP-1
receptor agonist (1).
Saxenda should not be used with insulin (1, 5.4).
The effects of Saxenda on cardiovascular morbidity and mortality
have not been established (1).
The safety and efficacy of coadministration with other products for
weight loss have not been established (1).
Saxenda has not been studied in patients with a history of
pancreatitis (1, 5.2).
Saxenda delays gastric emptying. May impact absorption of concomitantly
administered oral medications. Use with caution (7).
Never share an injection pen, cartridge, or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.
Liraglutide can slow your digestion, and it may take longer for your body to absorb any medicines you take by mouth.
Tell your doctor about all your current medicines and any you start or stop using, especially:insulin; or oral diabetes medicine–Glucotrol, Metaglip, Amaryl, Avandaryl, Duetact, DiaBeta, Micronase, Glucovance, and others.
This list is not complete. Other drugs may interact with liraglutide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
WARNING AND PRECAUTIONS
Thyroid C-cell Tumors: See Boxed Warning (5.1).
Acute Pancreatitis: Discontinue promptly if pancreatitis is suspected. Do
not restart if pancreatitis is confirmed (5.2).
Acute Gallbladder Disease: If cholelithiasis or cholecystitis are suspected,
gallbladder studies are indicated (5.3).
Serious Hypoglycemia: Can occur when Saxenda is used with an insulin
secretagogue (e.g. a sulfonylurea). Consider lowering the dose of antidiabetic
drugs to reduce the risk of hypoglycemia (2, 5.4).
Heart Rate Increase: Monitor heart rate at regular intervals (5.5).
Renal Impairment: Has been reported postmarketing, usually in association
with nausea, vomiting, diarrhea, or dehydration which may sometimes
require hemodialysis. Use caution when initiating or escalating doses of
Saxenda in patients with renal impairment (5.6).
Hypersensitivity Reactions: Postmarketing reports of serious
hypersensitivity reactions (e.g., anaphylactic reactions and angioedema).
Discontinue Saxenda and other suspect medications and promptly seek
medical advice (5.7).
Suicidal Behavior and Ideation: Monitor for depression or suicidal thoughts.
Discontinue Saxenda if symptoms develop (5.8)
Liraglutide is usually given once per day. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Do not use Saxenda and Victoza together. These two brands contain the same active ingredient but they should not be used together.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
Liraglutide is injected under the skin at any time of the day, with or without a meal. You will be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.
Liraglutide comes in a prefilled injection pen. Ask your pharmacist which type of needles are best to use with your pen.
Your care provider will show you the best places on your body to inject liraglutide. Use a different place each time you give an injection. Do not inject into the same place two times in a row.
Do not use the medicine if it has changed colors or looks cloudy, or if it has particles in it. Call your pharmacist for new medicine.
Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.
Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and close friends know how to give you this injection in an emergency.
Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination, blurred vision, headache, and tiredness.
Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.
Use a disposable needle only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof “sharps” disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.
Liraglutide is only part of a complete treatment program that may also include diet, exercise, weight control, regular blood sugar testing, and special medical care. Follow your doctor’s instructions very closely.
Storing unopened injection pens: Store in the refrigerator. Do not freeze liraglutide, and throw away the medication if it has become frozen. Do not use an unopened injection pen if the expiration date on the label has passed.
Storing after your first use: You may keep “in-use” injection pens in the refrigerator or at room temperature. Protect the pens from moisture, heat, and sunlight. Use within 30 days. Remove the needle before storing an injection pen, and keep the cap on the pen when not in use.
Skip the missed dose and use the next regularly scheduled dose. Do not use extra medicine to make up the missed dose.
Call your doctor for instructions if you miss 3 or more doses of Saxenda
Get emergency medical help if you have signs of an allergic reaction: hives; fast heartbeats; dizziness; trouble breathing or swallowing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have: racing or pounding heartbeats;
sudden changes in mood or behavior, suicidal thoughts; severe ongoing nausea, vomiting, or diarrhea;
signs of a thyroid tumor–swelling or a lump in your neck, trouble swallowing, a hoarse voice, feeling short of breath; gallbladder problems–fever, upper stomach pain, clay-colored stools, jaundice (yellowing of your skin or eyes);
symptoms of pancreatitis–severe pain in your upper stomach spreading to your back, nausea with or without vomiting, fast heart rate;
severely low blood sugar–extreme weakness, confusion, t:nausea remors, sweating, fast heart rate, trouble speaking, nausea, vomiting, rapid breathing, fainting, and seizure (convulsions); or kidney problems–little or no urination; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath.
Common side effects may include(especially when you start using liraglutide), vomiting, stomach pain; diarrhea, constipation;headache, dizziness; or feeling tired.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects
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